What side effects are associated with this type of intervention?

Common treatments for tauopathies, such as Alzheimer's disease, include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Known side effects of cholinesterase inhibitors include nausea, vomiting, diarrhea, muscle cramps, and insomnia. Memantine can cause dizziness, headache, confusion, and constipation. Radiotracers like 11C HY-2-15, used for diagnostic purposes, generally have minimal side effects, but may include mild reactions at the injection site and rare allergic reactions.

What prior FDA approvals exist?

There have been no FDA approvals specifically for tau-targeting treatments in Tauopathies similar to the radiotracer 11C HY-2-15. However, there are ongoing studies and trials, such as the phase 1b trial of the anti-tau monoclonal antibody BIIB092, which has shown to be well-tolerated in progressive supranuclear palsy. This indicates a growing interest in tau-targeted therapies, although definitive FDA-approved treatments are still pending.

What other types of research exist?

Promising novel alternatives to 11C HY-2-15 for Tauopathies patients include 18F-AV-1451 (also known as Flortaucipir), 18F-PI-2620, and 18F-MK-6240. These radiotracers have shown potential in binding to tau protein deposits and are being actively studied for their diagnostic capabilities in tauopathies.

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11C-HY-2-15 Radiotracer for Tauopathies

Q: What is the mechanism of action of this treatment?

The most common treatments for Tauopathies focus on reducing tau protein aggregation, enhancing the clearance of tau aggregates, and stabilizing microtubules to maintain neuronal function. These treatments are crucial for patients as they aim to slow down or halt the progression of neurodegeneration caused by tau pathology. Imaging techniques, such as the use of radiotracers like 11C HY-2-15 for alpha-synuclein, are important for monitoring the effectiveness of these treatments and understanding disease progression, although 11C HY-2-15 specifically targets alpha-synuclein rather than tau.

Phase < 1

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be male or female adults from 40 to 80 years of age

Be older than 18 years old

Must not have

Females who are pregnant or breastfeeding

Forms of parkinsonism other than PD, PSP, and MSA as defined above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special imaging substance to help doctors see abnormal protein deposits in the brains of people with certain neurological diseases. It targets patients with MSA, PD, PSP, and healthy volunteers to compare results. The substance works by lighting up problem areas in the brain on a scan.

Who is the study for?

Adults aged 40-80 with Multiple System Atrophy (MSA), Parkinson's disease (PD), progressive supranuclear palsy (PSP), or healthy volunteers can join. Participants must understand the study and consent, or have a partner to assist. Brain donation is optional for PD/MSA/PSP subjects.

What is being tested?

The trial tests a new brain imaging agent called 11C-HY-2-15 in MSA patients compared to those with PD, PSP, and healthy individuals. It involves neurological assessments, PET scans for amyloid and alpha-synuclein proteins, and MRI of the brain.

What are the potential side effects?

Potential side effects may include discomfort from imaging procedures like PET scans or MRIs, reactions to tracer injections such as mild pain or bruising at injection sites, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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My condition is not PD, PSP, or MSA.

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I cannot undergo imaging, have an arterial line or IV placed, or have blood drawn due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Organ biodistribution

PET uptake of tracer

Secondary study objectives

Adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 11C-HY-2-15 PETExperimental Treatment4 Interventions

Participants will undergo 11C-HY-2-15 PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

brain MRI

2010

Completed Phase 2

~70

Neurological assessments

2021

N/A

~120

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tauopathies focus on reducing tau protein aggregation, enhancing the clearance of tau aggregates, and stabilizing microtubules to maintain neuronal function. These treatments are crucial for patients as they aim to slow down or halt the progression of neurodegeneration caused by tau pathology. Imaging techniques, such as the use of radiotracers like 11C HY-2-15 for alpha-synuclein, are important for monitoring the effectiveness of these treatments and understanding disease progression, although 11C HY-2-15 specifically targets alpha-synuclein rather than tau.